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Completed

NCT Number: NCT02133105

Levosimendan Versus Dobutamine for Renal Function in Heart Failure

Although inotropes have a favorable effect on central hemodynamics in patients with heart failure, their effect on renal hemodynamics is incompletely defined. The purpose of this study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that patients treated with levosimendan will show greater increases in renal blood flow and glomerular filtration rate (GFR) than those treated with dobutamine.

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Key information

Conditions

Cardiorenal Syndrome Cardio-Renal Syndrome Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written, signed and dated informed consent
  • Male and Female subjects ≥18 years of age
  • Chronic congestive heart failure scheduled for right sided cardiac catheterization
  • Left ventricular ejection fraction ≤ 40% determined by echocardiography
  • Elevation of N Terminal-proBNP ≥ 500 ng/L
  • Cardiorenal syndrome (30ml/min ≤ estimated GFR ≤ 80 ml/min (MDRD)

Exclusion criteria

  • Acute heart failure, untreated
  • Systolic blood pressure < 80 mmHg
  • Tachycardia above 100 bpm
  • Angina Canadian Cardiovascular Society (CCS) class III or higher
  • Aortic stenosis
  • Hypertrophic cardiomyopathy
  • Restrictive cardiomyopathy
  • The presence of kidney disease diagnosed before heart failure
  • Administration of radiographic contrast < 1 week
  • Radiographic contrast allergy
  • In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation

Treatment and study plan

Levosimendan

Drug

Other names: Simdax

Dobutamine

Drug

Other names: Dobutrex

Primary outcomes

  1. Change in renal blood flow

    Time frame: 75 min minus baseline

    Para-aminohippuric acid (PAH) infusion clearance

  2. Change in glomerular filtration rate

    Time frame: 75 min minus baseline

    Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance

Secondary outcomes

  1. Change in renal vascular resistance

    Time frame: 75 min minus baseline

    Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure

  2. Change in central hemodynamics

    Time frame: 75 min minus baseline

    Right atrial pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, mean arterial pressure, cardiac output, pulmonary vascular resistance and systemic vascular resistance measured with a pulmonary artery thermodilution catheter.

  3. Change in renal oxygen consumption and oxygen extraction

    Time frame: 75 min minus baseline

    Oxygen consumption: Renal blood flow multiplied by arterial-renal venous oxygen difference.

    Oxygen extraction: Ratio of renal oxygen consumption to renal oxygen delivery

  4. Change in filtration fraction

    Time frame: 75 min minus baseline

    Ratio of glomerular filtration rate to renal plasma flow

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure

Acronym: ELDOR

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 7, 2014
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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